Full Press Release Details
NOVATO, Calif. , July 28, 2011 /PRNewswire/ --
| Financial Highlights ($ in millions, except per share data, unaudited) | |||
| Item | Q2 2011 | Q2 2010 Comparison | |
| Total BioMarin Revenue | $110.6 | 20.2% increase | |
| Total Net Product Revenue | $109.6 | 21.0% increase | |
| Naglazyme Net Product Revenue | $60.3 | 27.5% increase | |
| Aldurazyme BioMarin Net Product Revenue* | $17.3 | $17.5 | |
| Kuvan Net Product Revenue | $28.8 | 16.6% increase | |
| Firdapse Net Product Revenue | $3.2 | $1.1 | |
| GAAP Net Income (Loss) | $(5.1) | $(0.5) | |
| GAAP Net Income (Loss) per share | $(0.05) (basic and diluted) | $(0.00) (basic), $(0.01) (diluted) | |
| Non-GAAP Adjusted EBITDA | $13.9 | $17.5 | |
| Non-GAAP Adjusted EBITDA per share | $0.13 (basic), $0.12 (diluted) | $0.17 (basic), $0.15 (diluted) |
* Net product transfer revenue had no impact on net Aldurazyme revenue to BioMarin in the second quarter of 2011 and a negative $0.2 million impact on net Aldurazyme revenue to BioMarin in the second quarter of 2010.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) today announced financial results for the second quarter of 2011. GAAP net loss was $5.1 million ( $0.05 per diluted share) for the second quarter of 2011, compared to GAAP net loss of $0.5 million ( $0.01 per diluted share) for the second quarter of 2010. Non-GAAP adjusted EBITDA was $13.9 million ( $0.12 per diluted share) for the second quarter of 2011, compared to non-GAAP adjusted EBITDA of $17.5 million ( $0.15 per diluted share) for the second quarter of 2010. Non-GAAP adjusted EBITDA excludes depreciation and amortization, contingent consideration expense, interest income and expense, income taxes, stock compensation expense and material non-recurring items. The reconciliation of the non-GAAP measures to the comparable GAAP measure is detailed in the table provided near the end of the press release.
GAAP net loss for the six months ended June 30, 2011 was $9.4 million ( $0.09 per diluted share), compared to GAAP net income of $0.7 million ( $0.01 per diluted share) for the six months ended June 30, 2010 . Non-GAAP adjusted EBITDA was $32.9 million ( $0.28 per diluted share) for the six months ended June 30, 2011 , compared to non-GAAP adjusted EBITDA of $32.9 million ( $0.30 per diluted share) for the six months ended June 30, 2010 .
As of June 30, 2011 , BioMarin had cash, cash equivalents and short and long-term investments totaling $412.1 million , as compared to $394.0 million at the end of March 31, 2011 .
"We are very pleased with our performance in the first half of 2011," said Jean-Jacques Bienaime , Chief Executive Officer of BioMarin. "Our commercial portfolio has been growing steadily, and our pipeline has advanced significantly. We look forward to many clinical milestones over the next 18 months."
| Net Product Revenue (in millions) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2011 | 2010 | $ Change | % Change | 2011 | 2010 | $ Change | % Change | ||||||||
| Naglazyme (1) | $ | 60.3 | $ | 47.3 | $ | 13.0 | 27.5% | $ | 120.9 | $ | 95.9 | $ | 25.0 | 26.1% | |
| Kuvan (2) | 28.8 | 24.7 | 4.1 | 16.6% | 55.5 | 45.9 | 9.6 | 20.9% | |||||||
| Firdapse (3) | 3.2 | 1.1 | 2.1 | 190.9% | 6.3 | 1.2 | 5.1 | 100%+ |
(1) Changes in foreign currency rates, net of hedges, had a $1.1 million and $1.2 million positive impact on Naglazyme sales in the three months and six months ended June 30, 2011 , respectively. Naglazyme revenues experience quarterly fluctuations due to the timing of government ordering patterns in certain countries.
(2) The quantity of commercial tablets dispensed to patients in the U.S., increased 16.2 percent in the second quarter of 2011 compared to the second quarter of 2010 and increased 9.1 percent in the second quarter of 2011 compared to the first quarter of 2011.
(3) A product for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) which was launched in the EU in April 2010 .
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2011 | 2010 | $ Change | % Change | 2011 | 2010 | $ Change | % Change | ||||||||
| Aldurazyme revenue reported by Genzyme (4) | $ | 44.5 | $ | 43.7 | $ | 0.8 | 1.8% | $ | 87.2 | $ | 83.5 | $ | 3.7 | 4.4% | |
| Royalties due from Genzyme | 17.3 | 17.7 | (0.4) | 34.0 | 33.7 | 0.3 | |||||||||
| Incremental (previously recognized) | - | (0.2) | 0.2 | 2.0 | (2.0) | 4.0 | |||||||||
| Total Aldurazyme net product revenues (5) | $ | 17.3 | $ | 17.5 | $ | (0.2) | $ | 36.0 | $ | 31.7 | $ | 4.3 |
(4) Changes in foreign currency rates caused an increase to Aldurazyme sales by Genzyme of $3.1 million in the three months ended June 30, 2011 and an increase to Aldurazyme sales by Genzyme of $3.5 million for the six months ended June 30, 2011 .
(5) To the extent units shipped to third party customers by Genzyme exceeded BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenue from the royalty payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenue for the period.
| 2011 Guidance | |||
| Revenue Guidance ($ in millions) | |||
| Item | 2011 Guidance | Previous 2011 Guidance | |
| Total BioMarin Revenues | $436 to $465 | $422 to $452 | |
| Total Net Product Revenues | $429 to $458 | $416 to $446 | |
| Naglazyme Net Product Revenue | $225 to $240 | $211 to $225 | |
| Kuvan Net Product Revenue | Unchanged | $112 to $120 | |
| Aldurazyme Net Product Revenue to BioMarin | Unchanged | $79 to $83 | |
| Firdapse Net Product Revenue | $13 to $15 | $14 to $18 | |
| Selected Income Statement Guidance ($ in millions) | |||
| Item | 2011 Guidance | Previous 2011 Guidance | |
| Cost of Sales (% of Total Revenue) | Unchanged | 18% to 20% | |
| Selling, General and Admin. Expense | Unchanged | $164 to $174 | |
| Research and Development Expense | $200 to $205 | $195 to $205 | |
| Amortization and Contingent Consideration | $2 | $15 | |
| Interest Income | Unchanged | $3 | |
| Income Tax Expense (Benefit) | $14 | $15 | |
| GAAP Net Income (Loss) | $(43) to $(33) | $(52) to $(42) | |
| Stock Compensation Expense | $45 | $43 | |
| Non-GAAP Adjusted EBITDA | $49 to $59 | $51 to $61 |
Anticipated Upcoming Milestones
3Q 2011/4Q 2011: Top-line results for Phase II trial for PEG-PAL, including daily dosing and formulation studies 1Q 2012/2Q 2012: Initiation of Phase III trial for PEG-PAL 1Q 2012: Initiation of Phase I trial for BMN-111 for Achondroplasia 2H 2012: Top-line results for Phase III trial for GALNS for MPS IVA 2H 2012: Top-line results for PKU-016 Kuvan neurocognitive study 2H 2012: Top-line results for Phase I/II trial for BMN-701 for Pompe disease 4Q 2012/1Q 2013: Market authorization application filings for GALNS for MPS IVA 1Q 2013-3Q 2013: 510k clearance and commercial availability of the handheld blood Phe monitor for PKU
Research and Development Programs
BioMarin continues to make significant investments in research and development to ensure persistent growth of the company. The current pipeline includes programs in various stages of development that are focused on treating a range of serious unmet medical needs.
Advanced Clinical Programs
Mid-Stage Clinical Programs
Early-Stage Clinical Programs
Preclinical Programs
Non-GAAP Financial Information and Reconciliation
The above results for the three and six months ended June 30, 2011 and June 30, 2010 and financial guidance for the year ending December 31, 2011 are presented both as determined in accordance with GAAP and on a non-GAAP basis. As used in this release, non-GAAP income is based on GAAP Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) adjusted to exclude non-cash stock compensation expense, contingent consideration expense and certain nonrecurring material items (adjusted EBITDA).
The following tables detail the reconciliation of non-GAAP to GAAP financial metrics:
| Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted EBITDA | ||||||||
| (in millions) | ||||||||
| (unaudited) | ||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | Year Ending December 31, 2011 | ||||||
| NOTES | 2011 | 2010 | 2011 | 2010 | Guidance | |||
| GAAP Net Income (Loss) | $ (5.1) | $ (0.5) | $ (9.4) | $ 0.7 | $(43) - $(33) | |||
| Interest expense, net | 1.3 | 1.6 | 2.6 | 2.8 | 6 | |||
| Income tax expense | 3.9 | 1.1 | 8.7 | 1.7 | 14 | |||
| Depreciation | 6.3 | 4.4 | 12.7 | 8.4 | 25 | |||
| Amortization | 1.0 | 0.9 | 1.9 | 1.0 | 4 | |||
| EBITDA | 7.4 | 7.5 | 16.5 | 14.6 | 6 - 16 | |||
| Stock-based compensation | 10.6 | 9.2 | 21.0 | 17.7 | 45 | |||
| Gain on sale of equity investments | - | (0.9) | - | |||||
| Contingent consideration | (1) | (4.1) | 0.8 | (4.6) | 1.5 | (2) | ||
| Adjusted EBITDA | $ 13.9 | $ 17.5 | $ 32.9 | $ 32.9 | $49 - $59 | |||
| (1) Represents the changes in the fair value of contingent acquisition consideration payable for the period. |
BioMarin believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin's GAAP information because it provides additional information regarding the performance of BioMarin's core ongoing business, Naglazyme, Kuvan, Aldurazyme and Firdapse and development of its pipeline. By providing information about both the overall GAAP financial performance and the non-GAAP measures that focus on continuing operations, the company believes that the additional information enhances investors' overall understanding of the company's business and prospects for the future. Further, the company uses both the GAAP and the non-GAAP results and expectations internally for its operating, budgeting and financial planning purposes and uses the adjusted EBITDA methodology in establishing corporate goals for internal compensation programs.
Diluted Earnings Per Share Calculation
The calculation of GAAP diluted earnings per share for both the three and six months ended June 30, 2011 and 2010 excludes 19.1 million and 26.3 million shares, respectively, related to the outstanding convertible debt as their impact is considered antidilutive. Additionally, all other potentially issuable shares were considered antidilutive under the Treasury method, including stock options, restricted stock, potential future ESPP shares and shares in the Nonqualified Deferred Compensation Plan.
The calculation of non-GAAP adjusted EBITDA earnings per share for the three and six months ended June 30, 2011 excludes 172,000 shares related to common stock issued to the Nonqualified Deferred Compensation Plan, and 3.2 million shares related to a portion of the outstanding convertible debt for just the three months ended June 30, 2011 as their impact is considered antidilutive. No potentially dilutive shares were excluded in the calculation of the non-GAAP adjusted EBITDA earnings per share for the three and six months ended June 30, 2010 .
Conference Call Details
BioMarin will host a conference call and webcast to discuss second quarter 2011 financial results today, Thursday, July 28 , at 5:00 p.m. ET . This event can be accessed on the investor section of the BioMarin website at www.BMRN.com .
| Date: July 28, 2011 | |
| Time: 5:00 p.m. ET | |
| U.S. / Canada Dial-in Number: 866.761.0748 | |
| International Dial-in Number: 617.614.2706 | |
| Participant Code: 79527137 | |
| Replay Dial-in Number: 888.286.8010 | |
| Replay International Dial-in Number: 617.801.6888 | |
| Replay Code: 97774602 |
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany ; and Firdapse™ (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, amifampridine phosphate (3,4-diaminopyridine phosphate), which is currently in Phase III clinical development for the treatment of LEMS in the U.S., PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, and BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. For additional information, please visit www.BMRN.com . Information on BioMarin's website is not incorporated by reference into this press release.
Forward-Looking Statement
BioMarin®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of BioMarin Pharmaceutical Inc.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
| Contact: | ||
| Investors | Media | |
| Eugenia Shen | Bob Purcell | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 506-6570 | (415) 506-3267 |
| BIOMARIN PHARMACEUTICAL INC. CONSOLIDATED BALANCE SHEETS (In thousands of U.S. dollars, except share and per share amounts) | |||||
| June 30, 2011 | December 31, 2010 (1) | ||||
| ASSETS | (Unaudited) | ||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 112,956 | $ | 88,079 | |
| Short-term investments | 145,964 | 186,033 | |||
| Accounts receivable, net (allowance for doubtful accounts; $969 and $63, respectively) | 106,606 | 86,576 | |||
| Inventory | 112,299 | 109,698 | |||
| Other current assets | 36,286 | 33,874 | |||
| Total current assets | 514,111 | 504,260 | |||
| Investment in BioMarin/Genzyme LLC | 1,121 | 1,082 | |||
| Long-term investments | 153,206 | 128,171 | |||
| Property, plant and equipment, net | 216,496 | 221,866 | |||
| Intangible assets, net | 101,736 | 103,648 | |||
| Goodwill | 53,055 | 53,364 | |||
| Long-term deferred tax assets | 228,400 | 236,017 | |||
| Other assets | 12,267 | 14,215 | |||
| Total assets | $ | 1,280,392 | $ | 1,262,623 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accrued liabilities | $ | 82,035 | $ | 83,844 | |
| Total current liabilities | 82,035 | 83,844 | |||
| Convertible debt | 377,520 | 377,521 | |||
| Other long-term liabilities | 88,532 | 84,001 | |||
| Total liabilities | 548,087 | 545,366 | |||
| Stockholders' equity: | |||||
| Common stock, $0.001 par value: 250,000,000 shares authorized at June 30, 2011 and December 31, 2010 : 111,564,800 and 110,634,465 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively | 112 | 111 | |||
| Additional paid-in capital | 1,122,732 | 1,090,188 | |||
| Company common stock held by Nonqualified Deferred Compensation Plan | (3,903 | (1,965 | |||
| Accumulated other comprehensive income (loss) | (5,923 | 188 | |||
| Accumulated deficit | (380,713 | (371,265 | |||
| Total stockholders' equity | 732,305 | 717,257 | |||
| Total liabilities and stockholders' equity | $ | 1,280,392 | $ | 1,262,623 | |
| (1) December 31, 2010 balances were derived from the audited consolidated financial statements. |
| BIOMARIN PHARMACEUTICAL INC. CONSOLIDATED STATEMENTS OF OPERATIONS For the Three and Six Months Ended June 30, 2011 and 2010 (In thousands, except for per share data) (Unaudited) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2011 | 2010 | 2011 | 2010 | ||||||||||||||
| REVENUES: | |||||||||||||||||
| Net product revenues | $ | 109,616 | $ | 90,592 | $ | 218,692 | $ | 174,665 | |||||||||
| Collaborative agreement revenues | 153 | 176 | 278 | 377 | |||||||||||||
| Royalty and license revenues | 862 | 1,182 | 1,117 | 1,861 | |||||||||||||
| Total revenues | 110,631 | 91,950 | 220,087 | 176,903 | |||||||||||||
| OPERATING EXPENSES: | |||||||||||||||||
| Cost of sales (excludes amortization of developed product technology) | 19,263 | 14,401 | 40,059 | 31,813 | |||||||||||||
| Research and development | 52,909 | 35,649 | 97,889 | 65,746 | |||||||||||||
| Selling, general and administrative | 41,015 | 37,277 | 82,089 | 71,277 | |||||||||||||
| Intangible asset amortization and contingent consideration | (3,324) | 1,580 | (3,012) | 2,234 | |||||||||||||
| Total operating expenses | 109,863 | 88,907 | 217,025 | 171,070 | |||||||||||||
| INCOME FROM OPERATIONS | 768 | 3,043 | 3,062 | 5,833 | |||||||||||||
| Equity in the loss of BioMarin/Genzyme LLC | (667) | (864) | (1,209) | (1,555) | |||||||||||||
| Interest income | 798 | 1,035 | 1,580 | 2,225 | |||||||||||||
| Interest expense | (2,072) | (2,635) | (4,213) | (5,064) | |||||||||||||
| Net gain from sale of investments | - | - | - | 927 | |||||||||||||
| INCOME (LOSS) BEFORE INCOME TAXES | (1,173) | 579 | (780) | 2,366 | |||||||||||||
| Provision for income taxes | 3,904 | 1,056 | 8,668 | 1,692 | |||||||||||||
| NET INCOME (LOSS) | $ | (5,077) | $ | (477) | $ | (9,448) | $ | 674 | |||||||||
| NET INCOME (LOSS) PER SHARE, BASIC | $ | (0.05) | $ | (0.00) | $ | (0.09) | $ | 0.01 | |||||||||
| NET INCOME (LOSS) PER SHARE, DILUTED | $ | (0.05) | $ | (0.01) | $ | (0.09) | $ | 0.01 | |||||||||
| Weighted average common shares outstanding, basic | 111,114 | 101,712 | 110,884 | 101,431 | |||||||||||||
| Weighted average common shares outstanding, diluted | 111,114 | 101,834 | 110,884 | 104,347 |
| STOCK-BASED COMPENSATION EXPENSE | |||||||||
| Three Months Ended | Six Months Ended | ||||||||
| June 30, | June 30, | ||||||||
| 2011 | 2010 | 2011 | 2010 | ||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||
| Cost of sales | $ | 1,127 | $ | 781 | $ | 2,529 | $ | 1,809 | |
| Research and development | 4,024 | 3,442 | 7,698 | 6,623 | |||||
| Selling, general and administrative | 5,456 | 4,943 | 10,760 | 9,279 | |||||
| $ | 10,607 | $ | 9,166 | $ | 20,987 | $ | 17,711 |
SOURCE BioMarin Pharmaceutical Inc.